Hemodialysis Bloodlines recallZ-0070-2026 · B Braun Medical Inc · initiated Sep 30, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from B Braun Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
FDA root cause category: Process control
What the company is doing
On September 29, 2025, "URGENT MEDICAL DEVICE CORRECTION" letters dated September 24, 2025, were sent to customers. Actions to be taken: 1. Ensure full adherence to the product Instructions for Use (IFU). In particular, the instructions for secure connection of patient connectors should be followed to reduce the probability of air ingress or leakage. 2. Increase visual inspection of the bloodlines during treatment. If air ingress or leakage is observed, re-secure or tighten connection using the product IFU. In some instances, the dialysis treatment should be stopped. 3. If re-securement or tightening connections does not resolve the concern, replace bloodline at earliest clinically feasible time. 4. If possible, avoid high flow during treatment if microbubbles are present. B. Braun Medical Inc. (BBMI) Customer/User: 1. Review this notice in its entirety. Ensure that all users in your organization of the above-mentioned products, and other concerned personnel are informed about this voluntary correction. Post this notification where the affected products are stored. Note: Product is not being returned as part of this correction notification. a. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The correction is to be extended to the consumer level. 2. Return the completed Urgent Medical Device Correction Acknowledgement Form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). If you have any questions, contact Director, Corporate Communications at 484-240-8373. ****Update 03/24/2026****On March 5, 2026, URGENT MEDICAL DEVICE CORRECTION letters were sent update letters out to notify of additional 15 lots impacted by the recall.
Recall details
- Recall number
- Z-0070-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 30, 2025
- Posted by the FDA
- Oct 22, 2025
- Recalling firm
- B Braun Medical Inc
- Quantity
- 1298454 units (1589674 - 3/5/26 Expansion)
- Product code
- FJK
- FDA submissions
- K080807
- Distribution
- Domestic: US Nationwide Distribution.
Product description
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Model No. SL-2010M2096; UDI-DI 04046964367786; Lot Numbers: A2500119, A2500121, A2500128, A2500129, A2500130, A2500132, A2500133, A2500134, A2500149, A2500150, A2500151, A2500180, A2500181, A2500182, A2500185, A2500198, A2500199, A2500200, A2500203, A2500204, A2500205, A2500206, A2500207, A2500208, A2500209, A2500210, A2500211, A2500212, A2500213, A2500214, A2500215, A2500216, A2500217, A2500218, A2500219, A2500220, A2500246, A2500247, A2500248, A2500249, A2500250, A2500251, A2500257, A2500258, A2500259, A2500260, A2500261, A2500262, A2500267, A2500268, A2500269, A2500273, A2500274, A2500275, A2500276, A2500277, A2500278, A2500295, A2500298, A2500299, A2500300; ***Addded 3/24/2026***Additional Lots Identified A2500318, A2500319, A2500320, A2500321, A2500322, A2500323, A2500324, A2500325, A2500326, A2500327, A2500328, A2500329, A2500330, A2500356, A2500357;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Hemodialysis Bloodlines SL-2010M2096B. Braun Medical Inc. · Set, tubing, blood, with and without anti-regurgitation valve3 recalls3 deaths1,000 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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